Clinical trials are the primary way researchers determine if a new treatment is safe and effective in people. Additionally, they determine whether the treatment is more effective and/or has less harmful side effects than the current “standard of care” treatments. Currently, the only standard treatment for DIPG/DMG is radiation.
In recent years, clinical trials have provided researchers valuable information about DIPG/DMG. As researchers discover more about DIPG/DMG, they can adjust clinical trials to test new ideas. In the last decade, this information has helped in understanding the biology of DIPG/DMG tumors. Researchers are now optimistic that new and future clinical trials will lead to new standard of care treatments, which will enable much longer survival times and eventually a cure.
Clinical trial availability varies, and not all trials are available in all geographical locations. Inclusion and exclusion criteria must be met before a patient can enroll into a clinical trial. The trial will have an FDA-approved protocol that allows doctors to enroll patients to try certain treatments. Your oncology team may provide you trial options based on geographical availability.
Many of the current trials for DIPG/DMG require a biological understanding of the tumor, which can only be discovered through a biopsy. This biological understanding includes identification of mutations present in the tumor. Studies are now being designed to provide individualized therapy based on specific mutations found in DIPG/DMG.
Clinical trials are conducted in phases
All clinical research trials will include an Institutional Review Board (IRB) informed consent (IC). The IC will need to be reviewed and signed by a parent or guardian of the patient. The IC will explain the operation of the clinical trial, advise on what you can expect along the way, and provide information about the study medication.
Typically the cost of the medication or agent is covered by the trial when accepted into a clinical trial. However, some medical expenses may be the responsibility of the patient or family. You should have a clear understanding of your financial responsibility prior to entering the trial. Sometimes clinical trials in the United States may not be available to international patients due to individual institutional requirements such as U.S. medical insurance.
Please refer to https://www.clinicaltrials.gov and search for DIPG and/or DMG to view current clinical trials.